This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.

开始日期2025-11-01

申办/合作机构

NovelMed Therapeutics, Inc.

NCT06454110 / Not yet recruiting临床2期

A Phase II, Open-Label Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.

开始日期2025-11-01

申办/合作机构

NovelMed Therapeutics, Inc.

NCT05684159 / Not yet recruiting临床2期

A Phase II, Open-Label Study of NM8074 in Patients with Atypical Hemolytic Uremic Syndrome (aHUS)

This is a Phase II, open-label study designed to determine if intravenously administered NM8074 results in remission from TMA in treatment-naïve aHUS patients.

开始日期2025-07-01

申办/合作机构

NovelMed Therapeutics, Inc.

100 项与 Ruxoprubart 相关的临床结果

登录后查看更多信息

100 项与 Ruxoprubart 相关的转化医学

登录后查看更多信息

100 项与 Ruxoprubart 相关的专利（医药）

登录后查看更多信息

项与 Ruxoprubart 相关的新闻（医药）

2024-09-02

·PRNewswire

Roche's PIASKY Approval for Paroxysmal Nocturnal Hemoglobinuria Treatment Will Give Tough Competition to AstraZeneca and Other Pharma Companies | DelveInsight

Following achievements in Asia, Roche's PNH treatment drug PIASKY (crovalimab) received its first FDA approval. This approval has spiked the competition between Roche and current market leader AstraZeneca. Additionally, the other pharma companies also geared up to launch their respective lead assets. LAS VEGAS, Sept. 2, 2024 /PRNewswire/ -- Paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder, shows a triad of features: intravascular hemolysis, thromboembolic events, and cytopenia. Manifestations vary among patients, making classification based on typical presentations challenging due to the disease's unpredictable nature. In 2023, the Paroxysmal Nocturnal Hemoglobinuria diagnosed prevalent cases were ~12,000 cases in the 7MM, which might reach ~13,000 cases by 2034. In the 7MM, the highest number of paroxysmal nocturnal hemoglobinuria diagnosed prevalent cases were observed in the US. Until 2007, PNH was a devastating disease without treatment for hemolysis and thrombosis, the leading cause of death in patients. However, the last decade saw a revolutionary shift with the advent of the anti-C5 agent eculizumab. It significantly reduced hemolysis, decreased transfusion dependency, and, crucially, lowered the thrombosis rate. The disease-modifying therapeutic strategy for paroxysmal nocturnal hemoglobinuria includes complement inhibition therapy, with drugs like SOLIRIS, ULTOMIRIS, and EMPAVELI approved by the FDA, and considered the gold standard. SOLIRIS, the pioneering therapy for PNH, was succeeded by ULTOMIRIS, both developed by Alexion Pharmaceuticals, offering C5 inhibitors as essential therapeutic options. Recent approvals of factor B and D inhibitors like FABHALTA (iptacopan) in the US and VOYDEYA (danicopan) in Japan aim to offer improved treatment with fewer side effects. Learn more about the FDA-approved paroxysmal nocturnal hemoglobinuria drugs @ Drugs for Paroxysmal Nocturnal Hemoglobinuria Treatment The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended crovalimab for treating PNH in adults and adolescents aged 12 and above in June 2024, based on findings from the global Phase III COMMODORE 2 clinical trial. The FDA accepted a biologics license application for crovalimab in September 2023 and subsequently approved it in June 2024 for treating PNH in adults and adolescents aged 13 years and older. Genentech, a subsidiary of Roche, has made the drug available in the US. In Japan, Chugai Pharmaceutical submitted a new drug application for PiaSky to the Japan Ministry of Health, Labour, and Welfare (MHLW) in June 2023. The drug was approved in March 2024 and launched in May 2024 for patients with PNH aged 12 years and above. In February 2024, China's National Medical Products Administration (NMPA) approved crovalimab for treating PNH in adults and adolescents aged 12 years and older who have not previously received complement inhibitor treatment, following a priority review that began in August 2022. PiaSky is also undergoing review by other regulatory authorities, including those in Europe and Taiwan. To know more about paroxysmal nocturnal hemoglobinuria treatment options, visit @ New Treatment for Paroxysmal Nocturnal Hemoglobinuria The paroxysmal nocturnal hemoglobinuria market is crowded with so many companies working in the domain. Emerging PNH therapies include Pozelimab (REGN3918) + Cemdisiran, OMS906, NM8074 (ruxoprubart), and others, reflecting a dynamic evolution in treatment strategies. Discover which therapies are expected to grab major paroxysmal nocturnal hemoglobinuria market share @ Paroxysmal Nocturnal Hemoglobinuria Market Report Pozelimab is a novel, fully human monoclonal antibody currently under investigation. It aims to inhibit complement factor C5, thereby preventing the destruction of red blood cells (hemolysis) responsible for symptoms in conditions like Paroxysmal Nocturnal Haemoglobinuria (PNH) and other diseases influenced by complement pathway activity. This IgG4 antibody binds tightly to both wild-type and variant forms of human C5, effectively blocking its function. In its ongoing development, pozelimab is also being studied in combination with Alnylam's cemdisiran, a siRNA C5 inhibitor. This investigational combination therapy is aimed at treating various complement-mediated disorders, including PNH and myasthenia gravis. OMS-906 is currently being developed to treat paroxysmal nocturnal hemoglobinuria (PNH), complement 3 glomerulopathy (C3G), idiopathic immune complex-mediated glomerulonephritis (ICGN), and arthritis. It can be administered either subcutaneously or intravenously. This drug candidate is a monoclonal antibody designed to target mannan-binding lectin serine protease 3 (MASP-3) to exert its therapeutic effects. Discover more about drugs for paroxysmal nocturnal hemoglobinuria in development @ Paroxysmal Nocturnal Hemoglobinuria Clinical Trials The anticipated launch of these emerging therapies for paroxysmal nocturnal hemoglobinuria are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the paroxysmal nocturnal hemoglobinuria market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that in 2023, the total paroxysmal nocturnal hemoglobinuria market size in the 7MM was USD ~1.4 billion, which is expected to reach USD ~2.5 billion by 2034. This growth can be attributed to the advances in disease mechanisms that drive new diagnostics and therapeutics, fueling drug development. Additionally, the PNH market foresees positive growth, propelled by increasing cases and upcoming therapies in the forecast period. DelveInsight's latest published market report titled as Paroxysmal Nocturnal Hemoglobinuria Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the paroxysmal nocturnal hemoglobinuria country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The paroxysmal nocturnal hemoglobinuria market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of PNH Gender-specific Cases of PNH The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM paroxysmal nocturnal hemoglobinuria market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this paroxysmal nocturnal hemoglobinuria market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the paroxysmal nocturnal hemoglobinuria market. Also, stay abreast of the mitigating factors to improve your market position in the paroxysmal nocturnal hemoglobinuria therapeutic space. Related Reports Paroxysmal Nocturnal Hemoglobinuria Epidemiology Forecast Paroxysmal Nocturnal Hemoglobinuria Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted paroxysmal nocturnal hemoglobinuria epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Paroxysmal Nocturnal Hemoglobinuria Pipeline Paroxysmal Nocturnal Hemoglobinuria Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key paroxysmal nocturnal hemoglobinuria companies, including Biocad, AKARI Therapeutics, Amgen, MorphoSys, Ra Pharmaceuticals, Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, among others. Aplastic Anemia Market Aplastic Anemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key aplastic anemia companies, including Pfizer, BioLineRx Ltd., Regeneron Pharmaceuticals, Gamida Cell, Elixirgen, Hangzhou Zede Pharmaceutical Technology, Cellenkos, Hemogenyx Pharmaceuticals, among others. Aplastic Anemia Pipeline Aplastic Anemia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key aplastic anemia companies, including Pfizer, BioLineRx, Ltd., Regeneron Pharmaceuticals, Gamida Cell, Elixirgen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

上市批准优先审批临床3期

2024-06-17

·BioSpace

FDA Approves Phase II Clinical Trial for Ruxoprubart in ANCA Associated Vasculitis (AAV) – a Chronic Rare Disease in Nephrology

-- The United States FDA Clears Initiation of Efficacy Trial in Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) Patients APhase II, Efficacy Trial in adult AAV patients has been approved by the FDA. Ruxoprubart is a first-in-class treatment for sustaining remission in AAV patients as a conjunctive therapy along with Standard of Care (SOC) which includes corticosteroids plus Cyclophosphamide/Azathioprine or Rituximab. Ruxoprubart demonstrated an anticipated safety pro Phase I trial in healthy subjects in 2022. TAVNEOS® (avacopan) was approved by the FDA in 2022 for treating AAV. Ruxoprubart is being positioned as the next-generation AAV treatment based on its mechanism of action. NovelMed’s Ruxoprubart drug blocks the alternative pathway (AP) without blocking the complement classical pathway (CP), an important advantage in maintaining a healthy lifestyle. Recent commencement of Ruxoprubart proof-of-concept Phase II trial through intravenous (IV) administration in naïve PNH patients shows promising results with a clean safety and efficacy profile. The Subcutaneous (SC) route of administration is under regulatory review and is expected to start soon. Ruxoprubart is a multi-indication platform. Given the role of the alternative pathway in rare diseases, the antibody drug has the potential to treat multiple diseases, including ocular, inflammatory, renal, neurological, and hematological. CLEVELAND, June 17, 2024 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. proudly announces the U.S. Food and Drug Administration's (FDA) clearance on Ruxoprubart, the investigational drug, for commencing an efficacy trial targeting patients with ANCA Associated Vasculitis (AAV), a rare autoimmune chronic ailment characterized by inflammation in small blood vessels. Currently, the standard of care (SOC) for AAV requires high doses of Glucocorticoids, along with prolonged administration of other immunosuppressive drugs. However, this approach comes with severe side effects, including general immune suppression and toxicity from glucocorticoids, leaving unmet needs in managing the disease's impact on vital organs and associated adverse events (AEs). Results from Phase I and II trials of Ruxoprubart in PNH patients demonstrate the drug's selective blocking of the alternative pathway (AP) without affecting the classical pathway (CP), which is crucial for maintaining immunity. This selectivity presents a significant advantage over existing complement blockers approved by the FDA or under development, potentially eliminating the need for a Black Box Warning. In a forthcoming twelve-patient AAV study, Ruxoprubart will be evaluated alongside the SOC, akin to the trial conducted for TAVNEOS. Ruxoprubart is anticipated to outperform TAVNEOS due to its comprehensive control over the pathway responsible for generating three major toxins contributing to the disease pathology: C3a, C5a, and MAC. While TAVNEOS only targets C5a, Ruxoprubart aims to neutralize two powerful toxins including C3a and C5a, offering a potentially superior treatment approach. "We are thrilled to have gained FDA approval to address AAV in patients with an inadequate response to standard of care. Through this study, we aim to compare Ruxoprubart with historical data on TAVNEOS, hoping to improve AAV patients' lives substantially" says Dr. Rekha Bansal, Chief Executive Officer of NovelMed. Joseph Jankowski, Ph.D., VP, Business Development of NovelMed, expressed enthusiasm regarding the FDA’s clearance, stating, "The FDA's clearance of the Phase II clinical trial for AAV marks a significant milestone for Ruxoprubart, which harbors potential as a versatile platform for multiple indications." Ruxoprubart is positioned to compete with TAVNEOS with its potential for a superior safety and efficacy profile. Acquisition of TAVNEOS by Amgen for 3.7 Billion dollars underscores the value placed on treatments for AAV patients. Ruxoprubart is expected to be a next-generation product that can replace TAVNEOS. Ruxoprubart's selectivity and specificity, based on the clinical data from ongoing trials, hold promise not only for AAV, but also for several other renal disorders, including aHUS, and IgAN. The drug's potential to offer a superior safety and efficacy pro it apart and places it in a strong position within the market. The alternative pathway (AP) plays a pivotal role in managing anemia, inflammation, and tissue damage in various complement-mediated disorders, including AAV. NovelMed is committed to advancing the development of Ruxoprubart and addressing the unmet medical needs of patients with AAV and other complement-mediated disorders. The FDA's clearance of the Phase II trial represents a significant step forward in our mission to bring innovative and effective treatments to the market. We are actively exploring licensing, partnership, and acquisition opportunities to advance Ruxoprubart's development and approval across multiple rare disease indications. For further details, please visit . About ANCA Associated Vasculitis (AAV) Anti-Neutrophil Cytoplasmic Antibody-associated vasculitis (ANCA Vasculitis or AAV), is a rare autoimmune condition causing inflammation in blood vessels, often leading to swelling, narrowing, and sometimes blockage of blood vessels. It is characterized by the presence of Anti-Neutrophil Cytoplasmic Antibodies (ANCAs), targeting certain proteins within white blood cells, particularly neutrophils. It often causes a specific type of inflammation called crescentic glomerulonephritis, which can lead to kidney failure. Diagnosis of AAV involves a comprehensive assessment of medical history, physical examination, specific laboratory tests, imaging studies, and sometimes tissue biopsies. The current treatment approach primarily focuses on immune system suppression to alleviate inflammation and prevent further organ damage, utilizing corticosteroids and immunosuppressants. Despite being a rare and complex disease, advancements in treatment strategies are a must for continued improvement in the outcome of AAV patients. The prevalence of AAV in the United States is approximately 66,600 to 133,200 patients. TAVNEOS costs $75,051 annually per patient, with the potential to generate over 4 Billion in annual sales. About Ruxoprubart Ruxoprubart is a high affinity, humanized monoclonal antibody to Bb, selectively blocking the initiation and propagation of the alternative pathway (AP). By targeting the AP and sparing the CP pathway, Ruxoprubart holds promise for treating renal disorders, including ANCA vasculitis (AAV). Furthermore, Ruxoprubart shows therapeutic potential across a broad spectrum of rare diseases and disorders, including but not limited to hematological (PNH), renal (aHUS, IgAN), neurological (NMOSD), and ocular (GA and Uveitis). Clinical trials for Ruxoprubart can be found at , showing its potential to address various complement-mediated and associated illnesses where treatment options are inadequate or absent. About NovelMed NovelMed is a clinical-stage biopharmaceutical company dedicated to developing antibody treatments for numerous complement-mediated disorders, particularly rare (orphan) diseases. We aim to innovate and develop novel biologics to address unmet needs in rare disease treatment. NovelMed boasts a robust portfolio of intellectual property with broad applications in rare and common diseases. This includes Ruxoprubart's potential to treat a range of complement-mediated disorders associated with uncontrolled AP activation. As part of its antibody platform, NovelMed also offers humanized antibodies to C3b and Factor P (Properdin), effectively targeting the AP. NovelMed actively seeks licensing, partnership, and acquisition opportunities to advance antibody development through Phase III and approval in multiple rare disease indications. For more information, please visit News (novelmed.com). Ya Gao Email: bd@novelmed.com Tel: (216) 440 2696 Follow NovelMed on LinkedIn

临床2期上市批准临床1期免疫疗法

2024-02-12

·BioSpace

Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment

FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH. Ruxoprubart is an Anti-Bb antibody that selectively blocks the alternative pathway while maintaining the intactness of the classical pathway required for clearing infection. The drug has completed phase I trial in 40 healthy volunteers with a clean safety pro was well-tolerated across all doses. Total alternative pathway inhibition was achieved, with the duration of AP inhibition showing a dose-dependent response. Ruxoprubart is currently undergoing a Phase II trial in treatment naïve PNH patients, showing promising results. Ruxoprubart is potentially useful in other clinical indications, where the complement alternative pathway is dysregulated. The FDA has approved phase 1b/Phase II clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 Glomerulopathy (C3G), Atypical Hemolytic Uremic Syndrome (aHUS), and most recently, ANCA vasculitis (AAV). The ODD designation provides Ruxoprubart with a range of benefits, including financial incentives, regulatory support, and extended market exclusivity, ensuring that this groundbreaking treatment can reach those who need it. CLEVELAND, Feb. 12, 2024 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). FDA's recognition of Ruxoprubart as an orphan drug for PNH underscores its potential to fulfill a crucial need for individuals grappling with this disease condition. Ruxoprubart is currently undergoing a Phase II trial in treatment-naïve PNH patients, which aims to evaluate the safety and efficacy of the drug and bringing us one step closer to providing an effective and innovative therapy for PNH patients in USA and around the world. "We are delighted by the FDA's decision to grant orphan drug designation to Ruxoprubart, underscoring the pressing need for innovative therapeutic solutions for patients with PNH," says Robert Bard, VP Regulatory Affairs. This ODD approval marks a significant advancement in the therapeutic landscape with Ruxoprubart 's unique ability to selectively block the alternative pathway (AP) while preserving the classical pathway required for clearing infections in PNH patients. Orphan Drug Designation (ODD) The ODD from the US FDA is a special designation granted to facilitate the development and assessment of prospective new medications. The FDA's Office of Orphan Products Development bestows orphan status upon drugs in development for the treatment, diagnosis, or prevention of rare diseases or conditions impacting fewer than 200,000 people in the US. This Designation aims to offer various advantages to drug developers in order to bolster the creation of innovative medications. These advantages include the potential for market exclusivity lasting seven years upon FDA approval, eligibility for tax credits related to qualified clinical trials, waiver of application fees, reduced annual product fees, clinical protocol assistance, and the potential qualification for expedited development programs. Ruxoprubart (NM8074) Distinguishing itself from Iptacopan (Fabhalta) by exhibiting no affinity for Factor B, our lead candidate Ruxoprubart selectively binds to protein Bb of the alternative pathway. This humanized anti-Bb monoclonal antibody serves as a potent blocker of the Alternative Pathway. Having successfully completed the phase I trial in healthy volunteers with expected outcomes, Ruxoprubart has progressed to a phase II trial, focusing on treatment-naïve PNH patients in a multi-dose regimen. Notably, the Anti-Bb molecule marks a pioneering biologic undergoing testing in treatment-naïve PNH patients. FDA has also approved the initiation of Phase II trials for multiple indications, including C3 Glomerulopathy (C3G), Atypical Hemolytic Uremic Syndrome (aHUS), and ANCA vasculitis (AAV) with trials to be conducted in the United States. Overseas regulatory approvals cover trials for PNH for the adult population and aHUS, extending to adult and pediatric population. Paroxysmal Nocturnal Hemoglobinuria (PNH) The dysregulation of the Alternative Pathway (AP) is widely recognized as a pivotal factor influencing the course of PNH disease. Classified as an orphan disease, current PNH treatment options remain limited and imperfect. Current sanctioned treatments either hinder infection clearance or induce hyperlipidemia. PNH is characterized by low PNH-RBC clone size, hemolysis, hemoglobinuria, low hemoglobin levels, elevated LDH, and numerous other symptoms that can lead to chronic issues, including premature death if left untreated. Chronic symptoms and multiple organ damage are also prevalent in PNH patients. While FDA-approved anti-C3, C5, and Factor B drugs exist for PNH treatment with potential symptom management, they are not without significant side effects. The imperative for additional treatment options for PNH, both effective and well-tolerated, remains recognized, with the potential to improve the disease outcome. About NovelMed NovelMed is dedicated to pioneering novel biologics for diverse complement-mediated diseases. As the first to conceptualize and validate an anti-Bb antibody for chronic complement-mediated and complement-associated disorders, NovelMed advances its leading product candidate through clinical trials, primarily focusing on hemolytic and renal disorders. "Rooted in a commitment to creativity and compassion, NovelMed aims to deliver transformative therapies reshaping the treatment landscape for rare disease patients," says Dr. Rekha Bansal, Chief Executive Officer. Positioned as a leader in developing Alternative Pathway (AP)-targeted therapies, NovelMed is dedicated to tackling debilitating diseases in hematology, ophthalmology, nephrology, dermatology, and neurology. Seeking Partnership to Advance the Development of Ruxoprubart for Rare Diseases PNH, a hemolytic disorder resulting in a low PNH-RBC clone size, increased RBC transfusions, elevated LDH values, and decreased hemoglobin values, remains an orphan disease with limited treatment options. NovelMed is actively seeking licensing, investment, partnership, and acquisition opportunities to propel Ruxoprubart through further development and approval across multiple rare disease indications in various countries. For additional information, please visit . Contact: Ya Gao BD@novelmed.com (216) 440-2696

孤儿药临床2期临床1期临床结果

100 项与 Ruxoprubart 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
C3肾小球病	临床2期	-	NovelMed Therapeutics, Inc.	2025-11-01
免疫球蛋白a肾病	临床2期	-	NovelMed Therapeutics, Inc.	2025-11-01
非典型溶血性尿毒症综合征	临床2期	-	NovelMed Therapeutics, Inc.	2025-07-01
抗中性粒细胞胞质抗体相关性血管炎	临床2期	-	NovelMed Therapeutics, Inc.	2025-06-01
阵发性睡眠性血红蛋白尿症	临床2期	-	NovelMed Therapeutics, Inc.	2025-01-01
皮肌炎	临床2期	-	NovelMed Therapeutics, Inc.	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05646524 (GlobeNewswire) 人工标引	临床2期	阵发性睡眠性血红蛋白尿症一线	8	NM8074	(艱鑰襯遞構製鑰獵鏇壓) = favorable safety profile, with no safety concerns. 鏇鏇願築觸簾餘獵鏇範 (鏇艱廠觸簾願糧鑰鏇簾 ) 更多	积极	2023-10-30
PRNewswire 人工标引	临床1期	阵发性睡眠性血红蛋白尿症	40	NM8074	(構窪顧齋鬱襯鹽顧繭鑰) = NM8074 was safe at all doses and was well tolerated 廠壓窪衊憲膚遞餘簾構 (齋鹹選網蓋鹽餘憲鹽築 )	积极	2022-02-21